Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Graft System REF ESBF3614C103EE and ESBF3214C103E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.
- Company
- Medtronic Vascular, Inc.
- Recall Initiated
- June 7, 2021
- Recall Number
- Z-2136-2021
- Quantity
- 21 devices
- Firm Location
- Santa Rosa, CA
Reason for Recall
During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Distribution
U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.
Lot / Code Info
Endurant IIs Stent Graft System: Model (REF):ESBF3214C103E GTIN: 00643169439962 Serial Numbers: V29780773; V29780771; V29780759; Model (REF): ESBF3614C103EE GTIN: 00643169780460 Serial Numbers: V29781932; V29781933; V29781934; V29781935; V29781936; V29781937; V29781938; V29781939; V29781940; V29781941; V29781942; V29781943; V29781944; V29781945; V29781946; V29781947; V29781948; V29781951;
Root Cause
Under Investigation by firm
Action Taken
On 06/07/2021, the firm initiated a verbal notification regarding an "URGENT MEDICAL DEVICE RECALL" which informed customers that Earlier this week, Medtronic identified the potential for a specific subset of 20Fr Endurant II/IIs Stent Graft Systems to have the potential for the Radiopaque Marker to detach during deployment. There is evidence that devices that used one batch of graft cover subassemblies has a higher potential to exhibit this failure mode. This is an acute failure of the delivery system, there are no concerns with previously implanted stent grafts. We are requesting that you immediately refrain from using this specific subset of products and place it in quarantine until further notice. You will be receiving an official recall notice with instructions for product return for credit or replacement. Your Sales Representative will assist you with this process. We apologize for the inconvenience; however, this action is necessary to ensure the utmost patient safety with the use of our products. On 06/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-Day delivery that restated the verbal notification. The Customer Notification Letter instructed customers to: 1)Return all unused affected devices via their sales representative or calling customer service at 1-888-283-7868 or email rs.aorticorders@medtronic.com. 2)Complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. 3)Forward this notice to all those who need to be aware within their organization. For questions or assistance, contact Customer Service at 1-888-283-7868.